Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) MedDRA version: 8.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization
Conditions
Interventions
Trade Name: VISUDYNE (verteporfin)
Product Name: VISUDYNE
Product Code: BPD952
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: VERTEPORFIN
CAS Number: 129497785
Concentratio
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients of any race 50 years or older • Primary active subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component. If the lesion is classified as occult with no classic CNV component, the lesion must have evidence of recent disease progression as defined in the study glossary under “active lesion” • The total area of CNV (including both classic and occult components) encompassed within the lesion must be > 50% of the total lesion area • The total lesion are must have the Greatest Linear Dimension (GLD) = 5400 microns (~9 MPS Disc Areas [DA]) • BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320 Snellen equivalent) using an ETDRS chart measured at 4 meters distance • Patients who provide written and informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure • Patients willing and able to comply with all study procedures • Ocular conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia), or CNV secondary to causes other than AMD • Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion • Tear (rip) of the retinal pigment epithelium • Active, or history of, ocular inflammation or infection in the study eye within 30 days • Uncontrolled glaucoma in the study eye (defined as intraocular pressure, IOP = 25 mmHg despite treatment with two or more topical pharmacological anti-glaucomatous medication) • Any concurrent ocular condition in the study eye that may result in visual loss during the study • Prior Visudyne®, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye • Prior treatment with Macugen®, Lucentis™, Avastin [bevacizumab] or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Retaane [anecortave acetate], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD in the study eye (treatment of thefellow eye is permitted if administered > 30 days before Screening) • History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery more than 60 days prior to screening • History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening •History of Hypersensitivity or allergy to fluorescein, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components •Past (= prior 6 months) or currnet use of, or likely need for , systemic medications that are known to be toxic to the lens, retina or optic nerve, including deferoxamine, cholorquine/htdrochloroquine, tamoxifen, phenothiazidines and ethambutol •Any systemic medical condition that may interfere with the safety of the patient •Inability to obtain photographs, FAs, or OCT to document CNV, eg due to media opacity insufficient puillary dilation or lack of venous access •Use of other investigational drugs at the time of screening, or within 60 days (excluding vitamins and minerals) •Pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum pregnancy test (hCG>5mIU/mL) •Women of childbearing potential unless they meet the following definition of post-menopausal: 12 months of natural (spontaeous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40mIU/mL or six weeks post surgical bilateral oophorectomy with or without hyterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilisation (eg bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch oral) and double-barrier methods (any double combination of : IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervial cap). Periodic abstinence (eg calendar, methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation) • severe hepatic impairment or porphyria • current chronic use of systemic corticosteroids • prior and current use of systemic anti-VEGF drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Demonstrate that Visudyne® combination therapy is not inferior to Lucentis™ monotherapy with respect to the mean change from baseline in Best-Corrected Visual Acuity (BCVA) (letters) at Month 12. • Evaluate the proportion of patients with a treatment-free interval of at least 3 months duration at any timepoint following Month 2. ;Secondary Objective: • Demonstrate that Visudyne® combination therapy is superior to Lucentis™ monotherapy, based on the number of Lucentis™ retreatments administered following the Month 2 treatment. • Evaluate the time to first retreatment of Lucentis™ by comparing Visudyne® combination therapy with Lucentis™ monotherapy following the Month 2 Lucentis™ treatment • Assess the safety of Visudyne® combination therapy compared to Lucentis™ monotherapy as assessed by ophthalmic and vital signs evaluations and adverse AE reports over 24 months • Evaluate the efficacy of Visudyne® combination therapy compared to Lucentis™ monotherapy on BCVA changes from baseline as assessed by ETDRS charts and VA protocol over 24 months • Evaluate the efficacy of Visudyne® combination therapy compared to Lucentis™ monotherapy on changes in angiographic and OCT outcomes from baseline over 24 months • Assess the mean change from baseline in BCVA at Months 1, 2 and 3 to evaluate the onset of effect;Primary end point(s): The two primary efficacy variables are • mean change from baseline in best corrected visual acuity (BCVA) at month 12 • the proportion of patients with a treatment-free interval of at least 3 months duration at any timepoint following Month 2 The primary analysis will be performed on the ITT population using the LOCF approach for imputing missing data | — |
Countries
Austria, Belgium, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, United Kingdom
Outcome results
None listed